510(k) Report

510(k) · Cleared

Cleared

Camino Ventricular Drainage System

K932769510(k) TraditionalCleared Mar 30, 1995660-day reviewClass II21 CFR 882.5550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Camino Laboratories, Inc. · JXG Shunt, Central Nervous System And Components

Cleared on Mar 30, 1995 after a 660-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.

Decided
Mar 30, 1995
Review
660 days
Class
Class II
Product code
JXG
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2003: 1 descendant cleared2017: 1 descendant cleared2002: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK932769 Camino Ventricular Drainage SystemCamino Laboratories, Inc. · 1995
  2. Descendant · cites it directly · 5 of its ownK972994 External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997
  3. Descendant · 2 generations on · 2 of its ownK030289 Hermetic Plus External CSF Drainage Systems…Integra Lifesciences Corp. · 2003
  4. Descendant · 3 generations on · 1 of its ownK121248 Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF…Moller Medical GmbH · 2013
  5. Descendant · 2 generations on · 0 of its ownK170599 SureFlo EVD CatheterArkis Biosciences, Inc. · 2017 · Recalled
  6. Descendant · 4 generations on · 0 of its ownK150898 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1997: 12002: 12003: 12013: 12015: 12017: 1
1997high 1 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 6 · See all
  • K972994External CSF Drainage Management SystemsIntegra Neurocare, LLC · 1997 · cites it directly5descendants
  • K030289Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700, NL850-830NIntegra Lifesciences Corp. · 2003 · 2 generations on2descendants
  • K121248Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set (2000MM)…Moller Medical GmbH · 2013 · 3 generations on1descendant
  • K170599SureFlo EVD CatheterArkis Biosciences, Inc. · 2017 · 2 generations on0descendants
  • K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH · 2015 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932769Camino Ventricular Drainage SystemCamino Laboratories, Inc.1995—
+1K972994External CSF Drainage Management SystemsIntegra Neurocare, LLC1997—
+2K030289Hermetic Plus External CSF Drainage Systems, Ins-8301,Ins-8302,Ins-8700…Integra Lifesciences Corp.2003—
+3K121248Liquoguard CSF Liquoguard CSF Tubing Set (1500MM) Liquoguard CSF Tubing Set…Moller Medical GmbH2013—
+2K170599SureFlo EVD CatheterArkis Biosciences, Inc.20171
+4K150898LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mmMoller Medical GmbH2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200310
201310
201510
201710
FIG. 1 — Lineage of K932769, 1995–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JXG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JXG device

  1. #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972994External CSF Drainage Management SystemsIntegra Neurocare, LLC19975

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972994 (Integra Neurocare, LLC, 1997) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JXG devices

JXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXG

8in 2025

2007: 32008: 62009: 52010: 32011: 72012: 32013: 32015: 62016: 62017: 72018: 62019: 42020: 22021: 12022: 42023: 52024: 32025: 82026 (partial year): 2
2007high 8 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXG

255in 2025

2007: 184 days median2008: 60 days median2009: 106 days median2010: 30 days median2011: 136 days median2012: 78 days median2013: 108 days median2015: 276 days median2016: 143 days median2017: 90 days median2018: 102 days median2019: 101 days median2022: 101 days median2023: 134 days median2024: 90 days median2025: 255 days median
2007high 276 (2015) · low 30 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JXG

3in 2024

2008: 12009: 302011: 52012: 12013: 142014: 62017: 12020: 82023: 22024: 32026 (partial year): 1
2007high 30 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXG

1,198in 2025

2007: 6492008: 6302009: 6292010: 8122011: 7872012: 9772013: 1,0042014: 1,2512015: 9842016: 1,0912017: 1,3352018: 1,4842019: 1,2952020: 1,2062021: 1,4672022: 1,3292023: 1,2212024: 1,2142025: 1,198
2007high 1,484 (2018) · low 629 (2009)2025

MAUDE reports naming product code JXG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200731840649
20086601630
2009510630629
20103300812
201171365787
20123781977
20133108141,004
20140—61,251
201562760984
2016614301,091
201779011,335
2018610201,484
2019410101,295
20202—81,206
20211—01,467
2022410101,329
2023513421,221
202439031,214
2025825501,198
20262—1—
Cite this page

510(k) Report. “K932769: Camino Ventricular Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932769

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026